Sequential Neo-adjuvant Chemotherapy Followed by Capecitabine Vs. Conventional Adjuvant Chemotherapy in Breast Cancer
NCT ID: NCT03011060
Last Updated: 2017-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1588 participants
INTERVENTIONAL
2016-12-31
2025-02-28
Brief Summary
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Detailed Description
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Registered patients in stage Ⅰ- Ⅲ A breast cancer is randomly split into two groups(study group and control group).In the study group, patients achieving pCR will be followed up for 5 years while patients that do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine for 8 cycles after surgery. On the other hand, patients in the control group will accept surgeries and conventional adjuvant chemotherapies. Follow-up study will last 5 years. DFS and OS will be compared between the two groups.
This study provides an important basis and methods for the further treatment of patients after neo-adjuvant chemotherapy. It discusses whether neo-adjuvant chemotherapy could replace conventional adjuvant chemotherapy and become a new standard for breast cancer treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NAC not achieving pCR
Patients in the study group will accept neo-adjuvant chemotherapy. Among these patients, those who do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine after surgery. And then they will be followed up for 5 years.
Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.
Neo-adjuvant Chemotherapy
A preoperative chemotherapy based on anthracyclines and taxanes.
Capecitabine
Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.
NAC achieving pCR
Patients in the study group will accept neo-adjuvant chemotherapy. In these patients, those who reach to pCR after neo-adjuvant chemotherapy will be followed up for 5 years after surgery.
Neo-adjuvant Chemotherapy
A preoperative chemotherapy based on anthracyclines and taxanes.
Adjuvant Chemotherapy
Patients in the control group will accept surgeries and corresponding adjuvant chemotherapy.They will be followed up for 5 years after adjuvant chemotherapy.
No interventions assigned to this group
Interventions
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Neo-adjuvant Chemotherapy
A preoperative chemotherapy based on anthracyclines and taxanes.
Capecitabine
Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No gross or microscopic residual tumor after resection;
3. Clinical stage Ⅰ-stage Ⅲ A, no absolute surgical contraindications;
4. Eastern Cooperative Oncology Group(ECOG) score ≤1;
5. Accepting adjuvant chemotherapy within 15 days after surgery;
6. No peripheral neuropathy;
7. Normal bone marrow and organ functions:
1. Bone marrow function: ANC≥1500/mm3，PLT≥100000/mm3，HGB≥8g/dl
2. Renal function: serum creatinine≤1.5 times the upper limit of normal(ULN), Liver function: total bilirubin ≤1.5 times the upper limit of normal，AST≤2.5 times the upper limit of normal，alanine aminotransferase(ALT)≤2.5 times the upper limit of normal
3. Cardiac function:LVEF≥50%
8. Signed informed consent form.
Exclusion Criteria
2. Patients with organ dysfunction:
1. Renal function: serum creatinine\>1.5 times the upper limit of normal
2. Liver function: total bilirubin\>1.5 times the upper limit of normal，AST\>1.5 times the upper limit of normal, alanine aminotransferase(ALT)\>1.5 times the upper limit of normal or alkaline phosphatase (ALP) \>2.5 times the upper limit of normal
3. Cardiac function：LVEF\<50%;
3. Human epidermal growth factor receptor-2(HER-2) positive patients who cannot receive Herceptin treatment with a left ventricular ejection fraction(LVEF) less than 55%;
4. Patients allergic to docetaxel, capecitabine, epirubicin and cyclophosphamide;
5. Patients with severe systemic disease and/or uncontrollable infections;
6. Patients with previous malignancies, including contralateral breast cancer;
7. Patients with severe cardiovascular and cerebrovascular disease(i.e. Unstable angina, chronic cardiac failure, uncontrollable high blood pressure of \>150/90 mmhg, myocardial infarction and cerebrovascular accident) history within 6 months before randomization;
8. Pregnant or lactating women.
9. Patients who have cognitive or psychological impairment as well as cannot understand the test program or stand side effects, which will result in a suspension of the trial program and follow-up;
10. Patients without personal freedom or independent civil capacity.
18 Years
70 Years
FEMALE
No
Sponsors
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First Hospital of China Medical University
OTHER
The Second Affiliated Hospital of Harbin Medical University
OTHER
Qingdao University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Baotou Cancer Hospital
OTHER
The First Hospital of Jilin University
OTHER
Responsible Party
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Principal Investigators
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Fan Zhimin, Professor
Role: STUDY_CHAIR
The First Hospital of Jilin University
Locations
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the First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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References
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Fisher B, Brown A, Mamounas E, Wieand S, Robidoux A, Margolese RG, Cruz AB Jr, Fisher ER, Wickerham DL, Wolmark N, DeCillis A, Hoehn JL, Lees AW, Dimitrov NV. Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18. J Clin Oncol. 1997 Jul;15(7):2483-93. doi: 10.1200/JCO.1997.15.7.2483.
Bear HD, Anderson S, Smith RE, Geyer CE Jr, Mamounas EP, Fisher B, Brown AM, Robidoux A, Margolese R, Kahlenberg MS, Paik S, Soran A, Wickerham DL, Wolmark N. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer:National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006 May 1;24(13):2019-27. doi: 10.1200/JCO.2005.04.1665. Epub 2006 Apr 10.
Specht J, Gralow JR. Neoadjuvant chemotherapy for locally advanced breast cancer. Semin Radiat Oncol. 2009 Oct;19(4):222-8. doi: 10.1016/j.semradonc.2009.05.001.
Mathew J, Asgeirsson KS, Cheung KL, Chan S, Dahda A, Robertson JF. Neoadjuvant chemotherapy for locally advanced breast cancer: a review of the literature and future directions. Eur J Surg Oncol. 2009 Feb;35(2):113-22. doi: 10.1016/j.ejso.2008.03.015. Epub 2008 May 23.
Mieog JS, van de Velde CJ. Neoadjuvant chemotherapy for early breast cancer. Expert Opin Pharmacother. 2009 Jun;10(9):1423-34. doi: 10.1517/14656560903002105.
Alliot C. In vivo chemosensitivity-adapted preoperative chemotherapy in patients with early-stage breast cancer. Ann Oncol. 2005 Sep;16(9):1559-60; author reply 1560-1. doi: 10.1093/annonc/mdi287. Epub 2005 Aug 3. No abstract available.
Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Asola R, Kokko R, Ahlgren J, Auvinen P, Hemminki A, Paija O, Helle L, Nuortio L, Villman K, Nilsson G, Lahtela SL, Lehtio K, Pajunen M, Poikonen P, Nyandoto P, Kataja V, Bono P, Leinonen M, Lindman H; FinXX Study Investigators. Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: an open-label, randomised controlled trial. Lancet Oncol. 2009 Dec;10(12):1145-51. doi: 10.1016/S1470-2045(09)70307-9. Epub 2009 Nov 10.
M Toi, S-J Lee.Abstract S1-07: A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04). American Association for Cancer Research 76(4 Supplement):S1-07,2016
Other Identifiers
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JLUDBSCRH 001
Identifier Type: -
Identifier Source: org_study_id
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